Approval Probability
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Adjusted LOA
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Also known as mometasone furoate
GW685698X · 17 trials · 6 indications
The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3 (total score 0-9). The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS was a rating of the severity of symptoms over the previous 12 hours and was performed in the morning (AM rTNSS) and evening (post meridian \[PM\] rTNSS). The daily rTNSS was the sum of two assessments. The Baseline daily rTNSS was defined as the average of the daily rTNSS over the 4 consecutive 24-hour periods prior to randomization, including the assessment on the morning of randomization. Change from Baseline was calculated as the on-treatment value minus the Baseline.
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Pre-dose and pre-rescue bronchodilator (albuterol/salbutamol) trough FEV1 (the measurement of FEV1 performed at the end of the dosing interval) was measured electronically by spirometry in the evening at the Baseline (BL) through Week 8 clinic visits. The highest of 3 technically acceptable measurements was recorded. The Visit 3 FEV1 assessment was used as the Baseline value. Change from Baseline in trough FEV1 was calculated as the value at Week 8 minus the value at Baseline. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline trough FEV1, country, sex, age, and treatment group.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| GW685698X | EXPERIMENTAL | GW685698X |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm 2 | EXPERIMENTAL | - |
| Treatment 1 | EXPERIMENTAL | Subjects will receive GW685698X 800 microgram (mcg) single inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. |
| Treatment 2 | EXPERIMENTAL | Subjects will receive GW685698X 800 mcg containing magnesium stearate inhaled dose via a DISKUS inhaler. There will be a wash-out period of at least 5 days between doses. |
| Cohort A | EXPERIMENTAL | In Cohort A, subjects will be randomized (3:1) to receive once daily doses of GW685698X 400 microgram (mcg) containing magnesium stearate or placebo via DISKUS, for 14 days. |
| Cohort B | EXPERIMENTAL | In Cohort B, subjects will be randomized (3:1) to receive once daily doses of GW685698X (600 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days. |
| Cohort C | EXPERIMENTAL | InIn Cohort C, subjects will be randomized (3:1) to receive once daily doses of GW685698X (800 mcg) containing magnesium stearate or placebo via DISKUS, for 14 days. |
| Healthy subjects | ACTIVE_COMPARATOR | Subjects with normal liver function test will be administered a single oral inhaled dose of 400 micrograms (mcg) GW685698X in the morning of the study day. Each healthy subject will be matched as closely as possible for age, gender, bodyweight and race to a subject with impaired liver function. |
| Subjects with hepatic impairment | EXPERIMENTAL | Subjects with Child Pugh B hepatic dysfunction will be administered a single oral inhaled dose of 400 mcg GW685698X in the morning of the study day. |
| Name | Type | Description |
|---|---|---|
| GW685698X | DRUG | - |
| mometasone furoate | DRUG | - |
| Placebo | DRUG | placebo comparator |
| GW685698X 200mcg,GW685698X 200mcg and 400mcg | DRUG | - |
| GW685698X containing magnesium stearate | DRUG | GW685698X containing magnesium stearate will available with a unit dose strength of 400 mcg that will be inhaled via DISKUS |
Inclusion criteria: * History of perennial allergic rhinitis of 2 years, with a documented positive allergen test to an appropriate allergen. * Female patients of child-bearing potential must be willing to consistently and correctly use an acceptable method of birth control. Exclusion criteria: *...
GW685698X is an investigational small molecule developed by GSK plc for respiratory conditions. It has been studied in asthma and in allergic and vasomotor rhinitis, including perennial, seasonal, and perennial plus seasonal allergic rhinitis. It is an inhaled corticosteroid given once daily or twice daily in the asthma studies.
GW685698X has been studied for the treatment of asthma and for allergic and vasomotor rhinitis, including perennial allergic rhinitis, seasonal allergic rhinitis, and perennial plus seasonal allergic rhinitis. It remains an investigational agent and is not an approved therapy for these conditions.
GW685698X is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical program evaluating the compound in asthma and rhinitis, including the Phase 1 study in healthy Japanese male subjects and the Phase 2 asthma studies.
GW685698X is in Phase 2 development. Nine trials have been completed, including one Phase 1 study and multiple Phase 2 studies, with no trials currently active. The program has enrolled 2,810 participants across randomized, double-blind, controlled studies.
GW685698X has been evaluated in completed trials including NCT00972673, a Phase 1 study in healthy Japanese male subjects, and Phase 2 asthma studies NCT00766090, NCT00603746, and NCT00603382. The Phase 2 studies enrolled 190, 627, and 599 participants respectively, and all nine trials in the program are completed.